Clincosm LogoSign in Get a demo

ADAPT: Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

Sponsor
Argos Therapeutics (Industry)
Overall Status
Terminated
CT.gov ID
NCT01582672
Collaborator
(none)
462
Enrollment
125
Locations
2
Arms
65
Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

Condition or Disease Intervention/Treatment Phase
  • Drug: Standard Treatment
  • Biological: AGS-003
 Phase 3

Detailed Description

This study will investigate the combination of an autologous ribonucleic acid (RNA) electroporated dendritic cell (DC) based immunotherapy, AGS-003, plus standard treatment (initiating with sunitinib). The primary objective in this study is to determine the median OS achieved by this combination compared to the OS resulting from use of active control (standard treatment), in a population of adults with advanced renal cell carcinoma (RCC), with nephrectomy indicated, and with remaining metastatic disease.

Study Design

Study Type:
Interventional
Actual Enrollment :
462 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: AGS-003 + Standard Treatment

Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.

Biological: AGS-003
Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.
Active Comparator: Standard Treatment

Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.

Drug: Standard Treatment
Standard treatment for Renal Cell Carcinoma
Other Names:
  • Sunitinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study]

      Duration from randomization to death

    Secondary Outcome Measures

    1. Progression Free Survival [From date of subject randomization to date of progression; assessed up to 42 months]

    2. Tumor Response [From date of subject randomization to date of progression; assessed up to 42 months]

      Monitor for evidence of the following tumor responses: Objective response rate, Duration of overall response, and Disease control rate.

    3. Monitor treatment emergent adverse events between both arms [From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months]

      Compare adverse events between both arms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria for Tumor Collection:

    1. Diagnosis or clinical signs of advanced RCC

    2. Scheduled for cytoreductive or partial nephrectomy

    Key Exclusion Criteria for Tumor Collection:

    1. Known inability to undergo sunitinib treatment as currently labeled, due to pre-existing medical conditions

    2. Requirement for systemic chronic immunosuppressive drugs or corticosteroids

    3. Evidence of brain metastases prior to nephrectomy

    Key Inclusion Criteria for Treatment Study:

    1. Advanced disease, histologically assessed as RCC, with predominantly clear cell histology

    2. Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of the study participation per RECIST 1.1

    3. Subjects who are candidates for standard first-line therapy initiating with sunitinib

    4. Time from diagnosis to treatment < 1 year

    5. Karnofsky performance status (KPS) ≥ 70%

    6. Life expectancy of 6 months or greater

    7. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

    8. Adequate hematologic, renal, hepatic, and coagulation function

    9. Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug

    10. Normal ECG or clinically non-significant finding(s) at Screening

    11. Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study

    12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

    Key Exclusion Criteria for Treatment Study:

    1. Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy

    2. Prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a normal PSA

    3. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease

    4. Patients with 4 or more of the following risk factors:

    5. Hgb < LLN

    6. Corrected calcium > 10.0 mg/dL

    7. KPS < 80%

    8. Neutrophils > ULN

    9. Platelets > ULN

    10. Planned or elective surgical treatment post-nephrectomy for the direct management of RCC, within 28 days before Visit 1 (Week 0)

    11. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)

    12. Clinically significant cardiovascular conditions within 3 months prior to Randomization

    13. Significant gastrointestinal abnormalities

    14. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication

    15. Active autoimmune disease or condition requiring chronic immunosuppressive therapy

    16. Clinically significant infections, including human immunodeficiency virus, syphilis, and active hepatitis B or C

    17. Current treatment with an investigational therapy on another clinical trial

    18. Pregnancy or breastfeeding

    19. Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scottsdale Arizona United States 85259
    2 Little Rock Arkansas United States 72205
    3 La Jolla California United States 92093
    4 Los Angeles California United States 90024
    5 Los Angeles California United States 90048
    6 San Francisco California United States 94115
    7 Aurora Colorado United States 80045
    8 Colorado Springs Colorado United States 80909
    9 Denver Colorado United States 80211
    10 Miami Florida United States 33140
    11 Tampa Florida United States 33612
    12 Atlanta Georgia United States 30322
    13 Augusta Georgia United States 30912
    14 Marietta Georgia United States 30060
    15 Boise Idaho United States 83706
    16 Meridian Idaho United States 83642
    17 Chicago Illinois United States 60612
    18 Maywood Illinois United States 60153
    19 Springfield Illinois United States 62702
    20 Greenwood Indiana United States 46143
    21 Indianapolis Indiana United States 46202
    22 Indianapolis Indiana United States 46237
    23 Iowa City Iowa United States 52242
    24 Kansas City Kansas United States 66160
    25 Wichita Kansas United States 67226
    26 Metairie Louisiana United States 70006
    27 New Orleans Louisiana United States 70112
    28 New Orleans Louisiana United States 70121
    29 Baltimore Maryland United States 21201
    30 Baltimore Maryland United States 21204
    31 Boston Massachusetts United States 02114
    32 Burlington Massachusetts United States 01805
    33 Detroit Michigan United States 48201
    34 Detroit Michigan United States 48202
    35 Grand Rapids Michigan United States 49503
    36 Lansing Michigan United States 48912
    37 Minneapolis Minnesota United States 55455
    38 Rochester Minnesota United States 55905
    39 Saint Louis Missouri United States 63110
    40 Omaha Nebraska United States 68114
    41 Omaha Nebraska United States 68130
    42 Omaha Nebraska United States 68198
    43 Lebanon New Hampshire United States 03756
    44 Hackensack New Jersey United States 07601
    45 Albuquerque New Mexico United States 87131
    46 Albany New York United States 12208
    47 East Syracuse New York United States 13057
    48 New Hyde Park New York United States 11040
    49 New York New York United States 10016
    50 New York New York United States 10029
    51 Stony Brook New York United States 11794
    52 Syracuse New York United States 13210
    53 Charlotte North Carolina United States 28204
    54 Durham North Carolina United States 27710
    55 Raleigh North Carolina United States 27607
    56 Winston-Salem North Carolina United States 27157
    57 Cincinnati Ohio United States 45212
    58 Middletown Ohio United States 45042
    59 Toledo Ohio United States 43623
    60 Oklahoma City Oklahoma United States 73104
    61 Portland Oregon United States 97213
    62 Portland Oregon United States 97239
    63 Springfield Oregon United States 97477
    64 Allentown Pennsylvania United States 18103
    65 Danville Pennsylvania United States 17822
    66 Easton Pennsylvania United States 18045
    67 Hershey Pennsylvania United States 17033
    68 Philadelphia Pennsylvania United States 19111
    69 Philadelphia Pennsylvania United States 19140
    70 Pittsburgh Pennsylvania United States 15212
    71 Pittsburgh Pennsylvania United States 15232
    72 Providence Rhode Island United States 02906
    73 Charleston South Carolina United States 29425
    74 Greenville South Carolina United States 29605
    75 Myrtle Beach South Carolina United States 29572
    76 Sioux Falls South Dakota United States 57105
    77 Nashville Tennessee United States 37215
    78 Dallas Texas United States 75231
    79 Houston Texas United States 77030
    80 San Antonio Texas United States 78229
    81 San Antonio Texas United States 78240
    82 Salt Lake City Utah United States 84132
    83 Charlottesville Virginia United States 22908
    84 Virginia Beach Virginia United States 23462
    85 Seattle Washington United States 98101
    86 Seattle Washington United States 98109
    87 Milwaukee Wisconsin United States 53215
    88 Milwaukee Wisconsin United States 53226
    89 Winnipeg Manitoba Canada R3E 0V9
    90 Hamilton Ontario Canada L8N4A6
    91 London Ontario Canada N6A5W9
    92 Oshawa Ontario Canada L1G 2B9
    93 Ottawa Ontario Canada K1H8L6
    94 Greenfield Park Quebec Canada J4V2HI
    95 Montreal Quebec Canada H2L4M1
    96 Montreal Quebec Canada H3T1E2
    97 Quebec Canada G1R3S1
    98 Hradec Kralove Czechia 50005
    99 Liberec Czechia 46063
    100 Olomouc Czechia 77520
    101 Prague Czechia 10034
    102 Praha 8 Czechia 18081
    103 Budapest Hungary H-1062
    104 Budapest Hungary H-1122
    105 Debrecen Hungary H-4032
    106 Haifa Israel 31096
    107 Jerusalem Israel 91120
    108 Kfar Saba Israel 44281
    109 Rehovot Israel 76100
    110 Tel Hashomer Israel 52621
    111 Zerifin Israel 70300
    112 Roma Italy 00152
    113 Rome Italy 00144
    114 Badalona Spain 08916
    115 Barcelona Spain 08003
    116 Barcelona Spain 08035
    117 Madrid Spain 28033
    118 Madrid Spain 28046
    119 Madrid Spain 28050
    120 Sevilla Spain 41013
    121 Valencia Spain 46009
    122 Vigo Spain 36204
    123 Cambridge United Kingdom CB20QQ
    124 Norwich United Kingdom NR47UY
    125 Preston United Kingdom PR29HT

    Sponsors and Collaborators

    • Argos Therapeutics

    Investigators

    • Principal Investigator: Robert Figlin, MD, FACP, Cedars-Sinai Medical Center
    • Principal Investigator: Christopher G Wood, MD, FACP, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Argos Therapeutics
    ClinicalTrials.gov Identifier:
    NCT01582672
    Other Study ID Numbers:
    • AGS-003-007
    • 2012-000871-17
    First Posted:
    Apr 23, 2012
    Last Update Posted:
    Jun 14, 2018
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Argos Therapeutics
    RCC
    Kidney Cancer
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Sunitinib

    Study Results

    No Results Posted as of Jun 14, 2018